Gel bleeds, migration impact nearly all of women in Dutch case series

Cohesive and non-cohesive gel silicone breast implants (SBIs) bled silicones and resulted in extra-capsule migration of silicones, researchers reported.

In a single-center case series of 389 women, 98.8% had silicone particles present in tissues, while 86.6% had silicone particles in tissues surrounding the capsule and/or lymph nodes, indicating silicone migration, according to Henry B.P.M. Dijkman, PhD, of HAN University of Applied Sciences in Nijmegen, the Netherlands, and co-authors.

Researchers also found no differences in silicone gel bleed or migration between 44 women who received cohesive implants and 340 women who got “older or a newer type” of SBI (95.7% vs 99.1%, P=019), they wrote in JAMA Network Open.

Even though the study was retrospective and correlating bleed and migration with clinical symptoms was not possible, Dijkman and co-authors felt strongly enough about the results to conclude “the use of silicone gel–filled implants should be stopped until their safety has been proven… If patients experience complications from their SBIs, explantation (with complete excision of the capsule) should be offered. The costs of this procedure should be reimbursed by the health insurance companies.”

Cohesive implants—also known as “gummy bear” implants, textured gel implants, or form-stable implants—have a silicone gel shell and a silicone gel filling, which will retain its shape even if the shell is broken, explained a Healthline article reviewed by Catherine Hannan, MD, of the VA Hospital in Washington, DC. A potential “con” of cohesive implants is that that they may require a longer incision, so there is a higher risk of visible scarring.

Europe has a rocky history with cohesive implants, most notably with the French company Poly Implant Prothese (PIP). PIP began marketing cohesive implants in 2001, using an “in-house” formula of industrial-grade silicone, according to iMarc Research. By 2009, French surgeons were reporting unusually high rupture rates, with a 2014 retrospective analysis in Quantitative Imaging in Medicine and Surgery confirming a “higher incidence (36%) of prosthesis rupture observed with the PIP implants, compared to other breast implants.”

In 2018, French regulatory officials declined to renew approval for two types of textured implants from Allergan because of an increased risk for implant-associated anaplastic large cell lymphoma (ALCL) according to Fortune. However, BellaGel from Hansmed Bio of South Korea gained approved for use in the European Union back in 2008, but has yet to gain FDA approval.

In a 2020 study in the Archives of Plastic Surgery, Sa Ik Bang, MD, of Samsung Medical Center in Seoul, and colleagues reported on the 6-year data (building on 4-year data from 2019) from 103 Asian women who underwent breast implant (both reconstruction and augmentation) with the BellaGel product, and found a 1.15% implant rupture rate and a 2.3% capsular contracture rate.

“The BellaGel breast implant is the first breast implant manufactured by an Asian company… The results of this 6-year clinical study show the safety and effectiveness of BellaGel breast implants… however, 4 additional years of follow-up data must be obtained in this study to confirm the safety and effectiveness of BellaGel breast implants,” Bang’s group noted.

In a series of clinical cases (n=239 women; 478 breasts; mean age: 33.1 years) out of South Korea, Chul Hwan Seul, MD, PhD, of the JW Plastic Surgery Center in Seoul, and co-authors reported complications rates, including seroma, hematoma, and infection of ≤1% with BellaGel.

In 2006, the Allergan Natrelle and the Mentor MemoryGel did get green lights from the FDA, and those approvals were updated in 2011 after post-marketing studies. In 2020, the agency issued a recommendation for updated labeling for the cohesive implants to include “a boxed warning and a patient decision checklist… to better ensure certain information is received and understood by patients,” according to the FDA.

And in 2012, the FDA okayed the Sientra Ideal Implant. Thus far, that product has held up to scrutiny, with 2015 and 2018 studies in Plastic and Reconstructive Surgery showing a good safety profile for Ideal at 10 years, and overall low rupture and rotation rates with implants for all three companies.

The authors acknowledged that they did not have enough data to draw “conclusions about different brands of SBIs in regards to silicone migration,” but still argued that “most SBIs, regardless of brand or type, bled and showed the same pathogenesis.”

They collected capsule tissue and lymph node samples from women who underwent removal or revision of SBIs at their institution from January 1986 to August 2020. Missing data were extracted from the pathological reports and revision of the histology, the authors explained, while data analysis was done from January to May 2021.

The mean patient age was 50.5, and 365 women had capsular tissue removed, while 15 also had lymph nodes removed, and 24 had only lymph nodes removed. Dijkman’s group explained that there were six cases of implant-associated ALCL and all but one did not have a capsule resection in the pathology database (they had operations in other hospitals) so were not included in the study population.

The authors noted that age did not make a difference for the presence and location of silicones outside or inside the capsule. However, there was an inflammatory reaction, such as macrophages with phagocytosed silicones, seen in 92.5% of the patient population, “which is also associated with silicone leakage.”

In an accompanying invited commentary, Jenny Löfgren, MD, PhD, and Fredrik Lohmander, MD, both of the Karolinska University Hospital in Stockholm, called out many issues related to cohesive implants that still need to be evaluated.

They pointed out that the “indication for implant removal was not documented in the [current] study,” so “it is not known which symptoms, if any, the women had experienced.”

They also said that it was not likely that asymptomatic women made up the majority of women who had the implant removed or revised and, as a result, “the women in the study cannot be assumed to be representative of women with silicone breast implants in general. It is also not clear if the implants were ruptured or intact…Women with silicone breast implants sometimes present with symptoms consistent with suspected implant rupture as well as adenopathy.”

And they highlighted that nearly 93% of the women in the current study had evidence of “histiocytic reaction and/or inflammatory response. This indicates that silicone may not be inert. Whether this inflammatory response can lead to or contribute to the development of disease remains to be investigated in well-designed, unbiased, prospective trials and cohort studies.”

Löfgren and Lohmander said of implant-tied ALCL that “[t]heories regarding how silicone and biofilm with resulting low-grade chronic infection may trigger inflammatory response that could lead to the development of BIA-ALCL exist. Well-designed prospective research has yet to verify or refute these theories.”

Finally, they challenged the breast implant industry to step up and fund such studies, as every year, “millions of women receive silicone breast implants for reconstructive and aesthetic purposes.”

According to 2019 data from the International Society of Aesthetic Plastic Surgery, “breast augmentation remains the most common cosmetic surgical procedure, making up 15.8% of all procedures.” But late-pandemic times may put a serious dent in the breast implant market, because of the “Zoom Boom“—a significant increase in patients looking to undergo plastic surgery for facial changes, explained Lee Daniel, MD, of Aesthetic Plastic Surgery, in Eugene, Ore., in an American Society of Plastic Surgeons blog.

Study limitations include its retrospective nature, lack of sufficient data to make comparisons between differing SBI brands possible, inability to correlate silicone bleeds and migrations with clinical symptoms, and lack of data on numbers and types of consecutive implants.

  1. In a single-center case series of 389 women with silicone gel breast implants, 98.8% showed silicones in the tissues, and there was no differences in silicone gel bleed or migration among women who received cohesive implants versus those who received older or new implant type.

  2. Both cohesive and non-cohesive silicone gel breast implants leak silicones and may potentially harm patients.

Shalmali Pal, Contributing Writer, BreakingMED™

Dijkman and co-authors, as well as Löfgren and Lohmander, reported no relationships relevant to the contents of this paper to disclose.

Cat ID: 22

Topic ID: 78,22,730,22,467,935,191,691,192,925,159,162